Scientific title

Acronym

FHtomo

Study hypothesis

Mammographic screening is performed to detect breast cancer. Tomosynthesis is a new way of performing mammography that uses x-rays and a computer to generate three-dimensional (3D) images of the breast. The purpose of this study is to compare the accuracy of tomosynthesis and standard 2D mammography in the diagnosis of breast abnormalities, and in particular whether tomosynthesis can reduce the number of false alarms which lead to further tests.

Ethics approval

14/NW/0053; First MREC approval date 19/02/2014

Study design

Randomised; Interventional; Design type: Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format. Please use contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast

Intervention

Participants who have not had a screening mammogram before will have a standard 2D mammogram and DBT.

Women who have undergone screening mammography prior to entering the trial will be randomised using a web-based randomisation service to undergo either standard 2D mammography only followed a year later by 2D mammography and DBT, or the reverse (i.e. 2D mammography and DBT followed a year later by 2D mammography only). Participants will return to the standard screening schedule in the Family History Clinic following the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Recall to assessment rate; Timepoint(s): At screening

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2014

Overall trial end date

30/09/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women aged 40 to 49 years inclusive with an increased risk of breast cancer by virtue of their family history and who have been referred for screening by a family history or genetics service.(Note some women will be aged 50 when they have their second screen within the study)Target Gender: Female; Upper Age Limit 50 years ; Lower Age Limit 40 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 2904; UK Sample Size: 2904

Participant exclusion criteria

1. Inability to give informed consent, including inability to understand the nature and purpose of the study2. Breast implants3. Pregnancy4. Previous breast cancer